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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K004022
Device Name M3 (MIRCO-MULTILEAF COLLIMATOR
Applicant
Brainlab AG
Ammerthalstrasse 8
Heimstetten,  DE 85551
Applicant Contact STEFAN VILSMEIER
Correspondent
Brainlab AG
Ammerthalstrasse 8
Heimstetten,  DE 85551
Correspondent Contact STEFAN VILSMEIER
Regulation Number892.5050
Classification Product Code
IYE  
Date Received12/27/2000
Decision Date 03/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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